Does Virtual Reality Improve Symptom Burden in Dialysis Patients?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Reduction of symptom burden of dialysis patients and improvement of their mental wellbeing
研究概览
简要总结
The goal of this clinical trial is to investigate the use of virtual reality therapy in dialysis patients. The main question it aims to answer is: Does virtual reality improve symptom burden in dialysis patients and improve their mental wellbeing? Over a period of one month, one virtual reality therapy session of 30 minutes will be performed during each regular hemodialysis session. Since we will conduct a monocentric, crossover randomized controlled trial, the participants act as their own control group.
详细描述
Hemodialysis is a lifesaving therapy for patients with end stage kidney disease but comes with a high burden of physical and emotional symptoms that lower quality of life in dialysis patients. Dialysis mediated complications such as drops in blood pressure, nausea and muscle cramps results in refusal and a negative perception of this treatment. In dialysis patients, treatment-related burden results in deterioration in health related quality of life. During the past few years, Virtual reality (VR) has become more affordable and found its way into households as entertainment electronics but stepwise also into medicine. VR enables the user to view, interact and be immersed in a multisensory 3D virtual world. The aim of the current study is to reduce dialysis-related burden of symptoms by using virtual reality therapy during regular dialysis sessions and thereby improve quality of life among dialysis patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older than 18 years;
- •in treatment with thrice-weekly hemodialysis sessions;
- •regular hemodialysis duration of three to five hours
- •having no visual impairment
- •having no acoustic deficit
- •patient must be capable of speaking and understanding German or English
- •no signs of cognitive impairment
- •patient oriented in time and space
- •being able to give informed consent as documented by signature
排除标准
- •diagnosis of epilepsy
- •current pregnancy
研究组 & 干预措施
virtual reality therapy, then standard of care
During the intervention phase (A) participants will receive virtual reality therapy during their dialysis sessions over a period of one month. After a washout phase of one week, participants will run through a control phase (B, standard of care) also for a period of one month. Subjects will be randomized to an AB or BA sequence.
干预措施: virtual reality therapy (Other)
standard of care, then virtual reality therapy
During the control phase (B) participants will be treated according to standard of care over a period of one mont. After a washout phase of one week, participants will run through an intervention phase (A) and will receive virtual reality therapy during their dialysis sessions. Also for a period of one month. Subjects will be randomized to an AB or BA sequence.
干预措施: virtual reality therapy (Other)
结局指标
主要结局
Reduction of symptom burden of dialysis patients and improvement of their mental wellbeing
时间窗: 10 weeks
questionnaire
次要结局
- Evaluation of the effects of virtual reality therapy during hemodialysis on blood pressure(10 weeks)
- To assess the acceptability and appropriateness of using VRT during hemodialysis from the perspectives of patients(10 weeks)
- To assess the acceptability and appropriateness of using VRT during hemodialysis from the perspectives of clinical staff(10 weeks)
- Evaluation of the effects of virtual reality therapy during hemodialysis on heart rate(10 weeks)
- To test the internal consistency of the ESAS-r: Renal Score(10 weeks)
研究者
David Blum
Head of the department for Palliative Care of the University hospital Zurich
University of Zurich